FDA.reportPublic FDA data

Solventum™ Paradigm™

Primary DI
00197998226816
Brand
Solventum™ Paradigm™
Company
Solventum Germany GmbH
Model
46994
Catalog number
46994
Device description
Solventum™ Paradigm™ Temporization Material – A2 Shade, 46994, A2, 67 g Paste, Mixing Tips – Blue
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998226816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998226816001979982268161979982268160197998226816

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998054273Solventum™ Micropore™1530S-21530S-22026-10-23
00197998054327Solventum™ Micropore™1530-1181530-1182026-10-23
00197998054358Solventum™ Micropore™1530S-11530S-12026-10-23
00197998054396Solventum™ Micropore™1530SS-11530SS-12026-10-23
00197998307386Solventum™ Actisorb™ Silver 2206502206502202026-10-22
00197998307423Solventum™ Actisorb™ Silver 2201902201902202026-10-22
00197998307461Solventum™ Actisorb™ Silver 2201052201052202026-10-22
00197998115707Solventum™ Clinpro™67008670082026-10-09
00197998079917Solventum™ Durelon™38236382362026-10-08
00197998079955Solventum™ Durelon™38237382372026-10-08
00197998079962Solventum™ Durelon™38019380192026-10-08
00197998079986Solventum™ Durelon™38216382162026-10-08
00197998079993Solventum™ Durelon™38234382342026-10-08
00197998080005Solventum™ Durelon™38235382352026-10-08
00197998099984Solventum™ RelyX™56660566602026-10-08
00197998226724Solventum™ Protemp™46962469622026-10-08
00197998226731Solventum™ Protemp™46973469732026-10-08
00197998226748Solventum™ Protemp™46964469642026-10-08
00197998226755Solventum™ Protemp™46963469632026-10-08
00197998226762Solventum™ Protemp™46961469612026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942480707724FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
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06942480707823FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707830FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201790028FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17